AstraZeneca Submits Marketing Authorisation Application to European Union for VIMOVO™

PUBLISHED16 October 2009

Friday, 16 October 2009

AstraZeneca
and POZEN Inc. today announced that they have submitted a Marketing
Authorisation Application (MAA) in the European Union via the
Decentralised Procedure (DCP) for VIMOVO™ (enteric-coated
naproxen/immediate release esomeprazole magnesium, formerly known as PN
400) tablets, a product under investigation for the treatment of the
signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and
ankylosing spondylitis (AS) in patients who are at risk of developing
NSAID-associated ulcers. VIMOVO is a fixed-dose combination of enteric
coated naproxen and immediate release esomeprazole under co-development
by AstraZeneca and POZEN.

“Nearly 151 million people worldwide suffer from osteoarthritis.
However, up to one third of osteoarthritis patients change therapy in a
year, primarily due to lack of pain-relieving efficacy, and 60% of
patients do not continue to adhere to an NSAID and PPI combination
treatment after the third NSAID prescription,” said Lori Kreamer, Global
Product Vice President, AstraZeneca. “If approved, VIMOVO may provide
OA patients at risk of NSAID-associated ulcers a new treatment option
that offers both enteric coated naproxen and immediate release
esomeprazole in a single pill.”

In June 2009, POZEN submitted a New Drug Application (NDA) to the US
Food and Drug Administration (FDA) for VIMOVO. The NDA was accepted on
31 August, 2009, and is currently under review.

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